biostudies-literatureLurain KIntramural NIH HHSNCI NIH HHS432-442https://www.ebi.ac.uk/biostudies/studies/S-EPMC11779594biostudies-literatureUnknown43(4)<h4>Purpose</h4>Cancer Immunotherapy Trials Network 12 demonstrated safety of pembrolizumab in treating advanced cancer in people with HIV. Here, we report results of the Kaposi sarcoma (KS) cohort.<h4>Methods</h4>In this multicenter phase I trial, we enrolled participants with HIV-associated KS on antiretroviral therapy with CD4⁺ ≥50 cells/μL and HIV plasma RNA <200 copies/mL. Pembrolizumab 200 mg intravenously was administered once every 3 weeks for up to 35 cycles. The primary end point was safety, and the secondary end point was KS response by modified AIDS Clinical Trials Group Criteria.<h4>Results</h4>Thirty-two cisgender men enrolled with baseline median CD4⁺ T-cell count of 274 cells/µL. All but nine participants had received previous systemic KS therapy. PartJournal of clinical oncology : official journal of the American Society of Clinical OncologyCancer Immunotherapy Trials Network 12: Pembrolizumab in HIV-Associated Kaposi Sarcoma.PMC11779594HHSN261201500003IUM1 CA15496775N91019D00024HHSN261201500003CZ99 CA999999U01 CA154967Ekwede IWang CJRoshan RLurain KCornejo Castro EMWagner MJFriedlander PAKaiser JWright AMiley WGoyal GRamaswami RMenon MOdeny TAAbdul-Hay MWhitby DFling SPSharon ELabo NEulo VMoore KBhardwaj NMarshall VAYarchoan RKask ASUldrick TSHan EfalseCancer Immunotherapy Trials Network 12: Pembrolizumab in HIV-Associated Kaposi Sarcoma.<h4>Purpose</h4>Cancer Immunotherapy Trials Network 12 demonstrated safety of pembrolizumab in treating advanced cancer in people with HIV. Here, we report results of the Kaposi sarcoma (KS) cohort.<h4>Methods</h4>In this multicenter phase I trial, we enrolled participants with HIV-associated KS on antiretroviral therapy with CD4⁺ ≥50 cells/μL and HIV plasma RNA <200 copies/mL. Pembrolizumab 200 mg intravenously was administered once every 3 weeks for up to 35 cycles. The primary end point was safety, and the secondary end point was KS response by modified AIDS Clinical Trials Group Criteria.<h4>Results</h4>Thirty-two cisgender men enrolled with baseline median CD4⁺ T-cell count of 274 cells/µL. All but nine participants had received previous systemic KS therapy. Part2025-01-01T00:00:00Z2025 Feb2026-06-12T10:13:01.285Z2026-06-12T03:11:40.944ZS-EPMC117795943935698310.1200/JCO.24.0064010.1200/jco.24.00640